Germany's B. Braun is recalling one lot of dextrose injection medication distributed all over the United States after reports that the packaging can leak and in some instances contains visible microbial growth.
In a MedWatch alert issued late Tuesday, the FDA said the 5% dextrose injection is used for intravenous administration and sometimes as a diluent to deliver "compatible drug additives." The company began to notice an "adverse quality trend," the report stated, after customer complaints started to surface of leaky containers and visible particulate matter that ended up being microbial growth.
No adverse events have been reported associated with this issue, but the alert points out that injection with a nonsterile product can lead to serious infections and potentially death. B. Braun is contacting distributors and customers and urging healthcare providers to discontinue usage.
This isn't Braun's first time issuing a recall in the United States because of visible particulate matter. In May 2014, in the midst of a nationwide saline shortage, the company had to pull 1,300 saline solution 1,000-mL bags for the same reason, as well as nearly 54,000 partial additive bags containing 50 mL.
That saline shortage led the FDA to work with saline producers Baxter ($BAX), Hospira and Braun, in order to boost production for the U.S. market. Since then, though, the companies have faced a call for an FTC probe into their activities during the shortage, with some senators questioning whether they used the incident to bump prices and push sales.
Prior to that, in October 2013, B. Braun recalled one lot of an antibacterial infection treatment after visible organic particulate matter was found in some containers.
- here's the recall alert